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FDA 510(k)

Sterile Latex Surgical Gloves Powder Free

N.º K: K212596 · 2022-03-01

SolicitanteAmazing Rubber Products Pvt, Ltd.
Fecha de decisión2022-03-01
Código de productoKGO
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

Sterile Latex Surgical Gloves Powder Free is the device name listed in this FDA 510(k) record. The listed applicant is Amazing Rubber Products Pvt, Ltd.. It received FDA 510(k) clearance on 2022-03-01 under 510(k) number K212596. The device is classified under product code KGO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Sterile Latex Surgical Gloves Powder Free?

Sterile Latex Surgical Gloves Powder Free is a medical device that received FDA 510(k) clearance on 2022-03-01. The listed applicant is Amazing Rubber Products Pvt, Ltd.. The 510(k) number is K212596.

When did Sterile Latex Surgical Gloves Powder Free receive FDA 510(k) clearance?

Sterile Latex Surgical Gloves Powder Free received FDA 510(k) clearance on 2022-03-01, under 510(k) number K212596.

Who is the listed applicant for Sterile Latex Surgical Gloves Powder Free?

The FDA 510(k) record lists Amazing Rubber Products Pvt, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile Latex Surgical Gloves Powder Free?

The FDA product code for Sterile Latex Surgical Gloves Powder Free is KGO.

Ensayos clínicos relacionados

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Otros registros que enlistan a Amazing Rubber Products Pvt, Ltd. como solicitante

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K212584Blue Nitrile Examination Gloves Powder FreeK212597Amazing+ Latex Examination Powder Free GlovesK212586Amazing+

Dispositivos relacionados (Código: KGO)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K260558Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Latex Powder Free Surgical Gloves with Colloidal Oatmeal Tested for Use with Chemotherapy Drugs and Fentanyl CitrateHartalega NGC Sdn. Bhd.K253060Sterile Latex Powder Free Surgical GlovesProtect Gloves Company LimitedK250313Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric AcidHarps Europe Manufacturing GmbHK240790Polyisoprene Surgical glovesSuzhou Colour-Way New Material Co., Ltd.K232079Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green); Natural Rubber Latex (Strip&Coat)/(Strip&Pack) Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and FentanylWrp Asia Pacific Sdn. Bhd.K232444Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy DrugsGrand Work Plastic Products Co., Ltd.

Fuente oficial

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